Praful P. Dedhiya, Vrushti A. Rohit, Hitika B. Patel, Renu S. Chauhan, Shailesh A. Shah
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引用次数: 0
摘要
据报道,有多种分析技术可用于测定商品化制剂中的苯磺酸氨氯地平(AML)和吲达帕胺(IND)。然而,用于估算 AML 和 IND 组合的可持续/绿色分析技术在文献中却很少见。因此,本研究采用国家环境方法指数(NEMI)、绿色分析程序指数(GAPI)和分析绿色度(AGREE)工具,建立了一种快速、高灵敏度和可持续的高效薄层色谱(HPTLC)技术,用于同时估算 AML 和 IND。使用涂有 250 微米硅胶 60 GF254 的金属板进行色谱分离。以乙醇-乙酸乙酯-三乙胺(5:5:0.3, V/V)为流动相,在 288 纳米波长下进行密度检测。HPTLC 紫外检测法对 AML 和 IND 的线性范围分别为 300-1500 纳克/条和 100-500 纳克/条。采用建议的 HPTLC-UV 方法,发现市场上销售的制剂中 AML 和 IND 的检测率分别为 101.40 ± 1.55% 和 99.33 ± 1.39%。绿色 HPTLC-UV 技术的 AGREE 指数为 0.73,表明所建议的 HPTLC-UV 技术具有良好的绿色特性。该方法按照国际协调理事会(ICH)Q2(R1) 指南进行了验证。
Greenness profile assessment to HPTLC‒UV method for the simultaneous estimation of amlodipine besylate and indapamide by NEMI, GAPI, and AGREE tools
A wide range of analytical techniques has been reported for the determination of amlodipine besylate (AML) and indapamide (IND) in their commercialized formulations. Nevertheless, sustainable/green analytical techniques for estimating AML and IND in combination are scarce in literature. Accordingly, the present research was carried out to establish a rapid, highly sensitive, and sustainable high-performance thin-layer chromatography (HPTLC) technique for the simultaneous estimation of AML and IND using the National Environmental Method Index (NEMI), Green Analytical Procedure Index (GAPI), and analytical greenness (AGREE) tools. Metal plates coated with 250-µm silica gel 60 GF254 were utilized for chromatographic separation. Densitometric detection was carried out at 288 nm using mobile phase ethanol‒ethyl acetate‒triethylamine (5:5:0.3, V/V). The HPTLC with ultraviolet (UV) detection method was linear in the 300‒1500 ng per band and 100‒500 ng per band ranges for AML and IND, respectively. The assay of AML and IND in the marketed formulation was found to be 101.40 ± 1.55% and 99.33 ± 1.39%, respectively, using the suggested HPTLC‒UV method. The AGREE index for the greener HPTLC‒UV technique was found to be 0.73, suggesting an excellent greenness profile for the proposed HPTLC‒UV technique. The method was validated as per the International Council for Harmonisation (ICH) Q2(R1) guidelines.
期刊介绍:
JPC - Journal of Planar Chromatography - Modern TLC is an international journal devoted exclusively to the publication of research papers on analytical and preparative planar chromatography. The journal covers all fields of planar chromatography, on all kinds of stationary phase (paper, layer, gel) and with various modes of migration of the mobile phase (capillary action or forced flow).